Apparatus for performing diagnostic testing

ABSTRACT

The present invention relates to a hand-held diagnostic testing system and method employing apparatus that can effect a chemiluminescent reaction and record the same on photographic film.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of Provisional Application No.60/104,150, filed Oct. 14, 1998.

The present invention U.S. non-provisional patent application, Ser. No.09/412,845, entitled “Diagnostic Assay System and Method; filed on Oct.6, 1999, now U.S. Pat. No. 6,331,715.

BACKGROUND OF THE INVENTION

The present invention relates generally to diagnostic assay systems andmethods capable for multiple samples in a simple and reliable manner.

A wide variety of systems and approaches exist which allow theoccurrence and recording of luminescent reactions, such as of thechemiluminescent, or fluorescent type for qualitative and quantitativeresults. One class of analytical instruments typically used in thisfield is referred to as luminometers. Luminometers conduct and recordluminescent reactions generated, for instance, by a biological testfluid sample that contains a reagent of interest, such as an analyte,and a reagent in an assay element. Examples of these approaches includesingle-sample luminometers fitted with photographic multipliers;single-sample luminometers fitted with solid-state detectors; multiplesample luminometers; automatic luminometers with imaging systems basedon CCD cameras; and photographic camera type luminometers. Some of theforegoing devices using photographic films of the conventional andself-developing type for recording luminescent activity are describedin, for example, in U.S. Pat. Nos. 4,863,689; 5,035,866; and 5,188,965.Heretofore known prior art, tends to be limited in a number of ways,such as being expensive due to the expensive electronics required,training of personnel required because of their relatively complicatednature, and being relatively cumbersome in use and expensive inconstruction.

Despite the existence of a wide variety of known diagnostic luminescenttype testing systems and approaches, however, it is, nevertheless,desired to improve upon the overall ease, versatility, and reliabilityof such systems and their testing procedures, as well as reduce overallcosts associated with their construction and use.

SUMMARY OF THE INVENTION

In accordance with the present invention, one provision is, preferably,made for a hand-held, portable diagnostic assay system. The system isoperable for conducting and recording luminescent reactions, thatgenerate luminescent signals, such as chemiluminescent and fluorescentsignals, that are recordable an image recording medium, such as a filmassemblage of the self-developing type. Included in the system, in oneembodiment, is a housing assembly defining a light-tight enclosurecarrying at least the film unit and an exposure opening that opticallycommunicates the film unit and the luminescent read-out signal. A filmprocessing unit in the housing is operable for processing exposedself-developing film units passing therethrough. Provision is made for asample carrier means or assembly that has one condition for receiving aluminescent testing assembly and a second condition for exposing thefilm. The sample carrier assembly can carry, in a light-tight manner, atleast one luminescent testing assembly that is capable of generating aluminescent read-out signal recordable on the image recording medium inresponse to the testing assembly being actuated. Whenever the samplecarrier is in the second condition, the generated signal exposes thefilm unit. Developing the resultant latent image is initiated when thefilm unit is advanced from the housing after passing through the filmprocessing unit.

In an illustrated preferred embodiment, the sample carrier has anopening for receiving a test container of the luminescent testingassembly. The test container comprises a reservoir that stores aluminescent testing means; which in a preferred embodiment is in theform of a fluid that is sealed by means of a sealing device. A portionof the reservoir is transparent for allowing transmission of thegenerated read-out signal to the film through an open exposure opening.A sampling device of the luminescent testing assembly can sample asurface to be tested and is inserted, in a light-tight manner, withinthe test container such that a portion thereof is immersed in the fluid.If the sampling device contains a reagent that reacts with a reagent inthe assay fluid, the generated luminescent signal can expose the filmthrough the open exposure opening and transparent portion. In thisembodiment, movement of the sample carrier carrying the luminescenttesting assembly opens the exposure opening and registers thetransparent reservoir portion therewith for exposing the film. Movementof the sample carrier back to the receiving position closes the exposureopening. Further in another illustrated embodiment, the test containerincludes opaque means therein which serves, when the container is heldin the sample carrier, to block ambient light from reaching the exposureopening.

In another illustrated preferred embodiment, provision is made foreffecting and recording a luminescent read-out signal of a control testgenerally simultaneously with a luminescent signal of the test sample.

In an illustrated embodiment, a sample carrier assembly carries aluminescent sample test assembly and a luminescent control testassembly. Fluid transfer means, such as light-tight capillary grooves,allow transfer of the control and test fluids from separate portstherefor to the respective test assemblies. When the sample carrier isinserted into a recess in a processor housing containing the film, ashuttering mechanism is opened which allows luminescent read-out signalsemitted from the test sample and control luminescent testing assembliesto respectively expose the film. Removal of the sample carrier from theprocessor housing closes the shutter. The film can be advanced asindicated above in the other embodiments.

In still another illustrated embodiment of the present invention,provision is made for a means and method for achieving a quantificationof the luminescent signal generated and recorded on the film. In onesuch embodiment, such quantification is achieved by reason of an opticalfilter. The filter can have alternating light attenuating zones, such astransparent and opaque zones that act to delineate different sizedread-out signals. The different sized images correlate to correspondingdifferent test results. Because of the light attenuation, differentsized luminescent images will be visible through correspondinglydifferent sized attenuation zones; thereby providing a visualmeasurement of the test results. In yet other embodiments, thequantification can be obtained by pre-exposing the film with a gradationof different sized images. The different sizes correspond to differentpredetermined outputs of the luminescent signals. Alternately, provisionis for a film overlay comprising a series of different sized imagesthereon with each overlay image corresponding to different test outputs.In use the test image that is captured during the actual test can becompared to images on the overlay for quantifying the test result.

Methods are contemplated for conducting and recording read-out signalsthat can expose the image recording material.

It is an object of the present invention to provide an improved methodand system for conducting and recording luminescent reactions, whereinthe results can be immediately and reliably ascertained by an operator.

It is another object of the present invention to provide an improvedmethod and system for conducting and recording luminescent reactions ina hand-held assay processor using self-developing type film.

It is another object of the present invention to provide an improvedmethod and system of the last noted types for conducting and recordingmultiple sample tests.

It is another object of the present invention to provide an improvedmethod and system for conducting and recording luminescent reactions ina hand-held assay processor wherein both test sample and control fluidsare applied to corresponding different test strips.

It is another object of the present invention to provide an improvedmethod and system of the last noted types for conducting and recordingluminescent reactions wherein the output signals are recorded on filmand quantified.

It is another object of the present invention to detect the luminescentsignals electronically and print relevant information on the film.

It is another object of the present invention to provide for an improvedmethod and system which is simple and reliable to operate and which islow-cost in cost.

The above and other objects and features of the present invention willbecome apparent when reading the following description taken conjunctionwith the accompanying drawings wherein like parts are indicated by likereference numerals throughout the several views.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective schematic view illustrating severalcomponents forming one embodiment of a multiple sample diagnostic assaysystem of the present invention;

FIG. 1A is an enlarged and fragmented schematic view of a filmassemblage that can be used in connection with the invention;

FIG. 2 is a schematic exploded perspective view illustrating componentsof the assay system;

FIG. 3 is a bottom plan view of a sample carrier component of the assaysystem;

FIG. 4 is a bottom plan view of alternate embodiment of a samplecarrier;

FIG. 5 is a view of an alternate embodiment of a diagnostic assay systemof the present invention;

FIG. 6 is an enlarged schematic view of the interaction between the asample carrier and a shutter mechanism;

FIG. 7 is a plan view of an optical filtering arrangement for use in thediagnostic assay systems;

FIG. 8 is a plan view of another embodiment of an filtering arrangement;

FIG. 9 is a schematic view of yet another preferred embodiment of aprocessor of the present invention; and,

FIG. 10 is a cross-sectional view of a test container usable in theprocessor of FIG. 9.

DETAILED DESCRIPTION

Reference is made to FIGS. 1-3 for schematically illustrating one of thepreferred embodiments of a multiple sample diagnostic assay system 10.The diagnostic assay 10 includes a light-tight, processor housingassembly 12 having the general configuration depictedu and containingtherewithin a film box 14. Contained in light-tight relationship to thefilm box 14 is a film assemblage 16.

The preferred embodiment of the film assemblage 16 is similar to thatdescribed in copending and commonly assigned U.S. patent applicationsSer. No. 08/738,772; and Ser. No. 08/829,914 a description thereof isincorporated herein and made a part hereof. Since the construction ofthe film assemblage does not, per se, form and aspect of the presentinvention, only those details of such a film assemblage needed fordescribing the present invention will be set forth. Details of such aconstruction are set forth in the aforenoted copending patentapplication. Basically, the film assemblage 16 includes an elongatedstrip 18 comprising a plurality of self-developing film units 20 securedend-to-end to connection strips in alternating arrangement to form alongitudinal strip. Weakened portions in the connection strips arestructurally weakened to permit easy separation in a manner to bedescribed. Each of the film units is, preferably, of the integralself-developing integral type. In this connection, each of the filmunits 20 includes a tab or leader portion 20 a, an image recording area20 b, a pod 20 c of processing fluid located at a leading end portion,and a fluid trap 20 d at a trailing end. The photosensitive imagerecording area 20 b is positioned within the housing assembly so as tobe exposed to a read-out signal of a luminescent activity. Luminescentactivity or read-out as used in this specification includes anyluminescent activity such as of the chemiluminescent type, fluorescence,infrared and other signals that are recordable on an image recordingmaterial. The pod 20 c is positioned adjacent the processing means, aswill be described and a tab or leader portion 20 a of the leading filmunit protrudes from a film exit 24 in the device so that the film unitmay be manually grasped for pulling and processing of the film unit aswill be described. The film exit 24 is appropriately provided with flaps(not shown) or the like for providing a light-tight enclosure.

In the illustrated embodiment, the processor housing assembly 12includes a pair of generally rectangular and matable lower and upperplate-like processor housing portions 26 and 28. The housing portionsare hingedly connected as at 29 to permit loading of the film box withina complementary shaped compartment within the processor. The housingassembly 12 is, preferably, dimensioned to be hand-held and portable forproviding a self-contained and portable diagnostic assay system that isconvenient to use. The housing portions 26 and 28 can be made of anymaterial suitable to define, preferably, a light-tight enclosure 32.While a hinged coupling is described, a wide variety of approaches forjoining the two opposed housing components are envisioned. The lowerprocessor housing portion 26 is similar in construction to thatdescribed in the last-noted application and basically includes a filmsupporting wall (not shown) a processing fluid spreading structure 30(not shown) for spreading the processing fluid ruptured from the pod ina well-known manner. A lower spread roller 34 is rotatably supported inthe lower housing portion for cooperating with a biased upper spreadroller 36 in the upper housing portion 28 to define a pressure nip. Therollers 34 and 36 serve to rupture the pod and spread the processingfluid as a film unit passes therethrough. In addition, the nip acts toinexpensively retain the film assemblage 16 within the housing prior touse of the device. Accordingly, the film can be transported and handledwithout fear of it becoming dislodged or otherwise separated.

The upper housing 28 includes a generally rectangular recess 40 that haspivotally mounted thereon, as at 42, a shutter blade 44. The shutterblade 44 moves between light blocking and unblocking relationshipsrelative to an exposure opening 48 that is in optical communication withan image portion of a film unit. A light-seal plate 50 has aconstruction as shown to be mounted in and suitably secured to residewithin the recess of the upper housing and includes an aperture 52. Theplate 50 serves to rotatably mount, within the aperture 52 a rotatabletest sample carrier 54. The test sample carrier 54 has a generallycylindrical configuration with a reduced diameter portion that has asnug, light-tight fit within the plate. The test sample carrier 54includes a passage 56 extending longitudinally therethrough. A pluralityof linearly spaced apart stepped shoulders 58 a, 58 b are provided inthe passageway for supporting a test sample device. A pair of arcuatelyspaced apart and downwardly protruding opening and closing pins 60 and62; respectively, on the test sample carrier alternately engage theshutter to open and closed positions as the carrier is rotated inopposite directions; in a manner to be described. In this embodiment,the sample carrier can be manually grasped about its periphery andturned in either direction. Of course, manual means, such as handles ormotorized means can be used to rotate the sample carrier.

The device 10 is adapted for particular use in connection with aluminescent assay testing assembly 63 that includes an ampoule 64 and atest sample pick-up device 66 that is housed and cooperates with theampoule in a manner to be described. It will be understood, however,that the test system to be described is but one of several which can beused in conjunction with the device. In the illustrated embodiment, theluminescent testing assay assembly including the ampoule, fluid, andpick-up device are similar to that commercially available from Biotrace,Inc., Plainsboro, N.J. It will be understood that the device of thepresent invention can be used in connection with other similardiagnostic systems. The ampoule 64 includes a generally hollow tubularhousing for slidably receiving the pick-up device 66. Preferably, thehousing is made of transparent plastic, and has an open end portion 68that is adapted to receive the sample pick-up, and a closed end portion70. While the present embodiment of the ampoule includes a transparenthousing, it will be appreciated that need not be the case. In the latterregard, however, the closed end portion should be transparent in orderto transmit any luminescent activity; whereby the latter can form alatent image on the film. A sealing membrane 72 is located generallytransversely to the housing 67 so as to define a chamber or reservoir 74with the closed end portion in order to sealingly accommodate an assayfluid 76. The sealing membrane 72 is made of a thin-walled metallicmaterial that is impervious to fluid and ambient atmosphere. The sealingmembrane is adapted to be punctured by the sample pick-up device 66;when the latter is inserted therethrough. The assay fluid 76 can be onethat generates a chemiluminescent signal in response to a reagent, suchas ATP (Adenosine Triphosphate) being present on the sampling rings. ATPis used as an indicator of the presence of organic debris, such asmicroorganisms. The fluid 76 can be, for example, a Firefly reagentwhich generates a light signal in response to ATP collected on thesampling device 66. The sample pick-up device includes a handle 78, astem 80 and a plurality of laterally extending sampling rings 82. Thesampling rings 82 are used to engage a surface to be tested formicoroganisms. A user merely rubs the rings against a surface to betested, for instance, a food preparation surface and inserts thesampling ring into and through the membrane, whereupon the rings areimmersed into the assay fluid. If ATP is present, in significant amountson the sampling rings, it will react with the reagent in the fluid andgenerate a luminescent read-out signal that is recordable on the film.It is, of course, realized that the present invention contemplates useof a wide variety of fluids, membranes and sample pick-ups. Theforegoing materials provide, but one of many that can be used in thecontext of the present invention.

Reference is made in particular to FIG. 2, wherein the luminescenttesting assembly 63 is provided with an opaque means in the form of aplastic collar 86 being formed in combination with a segmented thetubular housing 67. The plastic collar 86 has a central axiallyextending passageway 87 through which the sample pick-up 66 is inserted.An upper end portion 88 is fit within a central passage of upper tubularportion 67 a and a lower end portion 90 is fit within a lower portion 67b of the housing above the sealing membrane. A projecting rim 92 extendsradially from the collar and is adapted to rest on the shoulder 67 a.

In operation, a user can, for example, wipe the sampling rings on asurface to be tested for the presence of ATP. The ampoule housing 67 isplaced within the passage 56 with the shoulder 58 b being engaged by thecollar rim 92 and the shoulder 58 a engaging a surface 67 c of thehousing wherein the transparent closed end portion enters a reduceddiameter portion of the passage 56, whereby the ampoule is in anupstanding position with respect to the sample carrier.

Prior to testing, the sample carrier is in a non-exposing mode, wherebythe passage 56 is circumferentially spaced from the aperture and theshutter blade is in the closed condition. To commence testing, the userinserts the test sample device 66 through the membrane so that thesampling rings are immersed within the assay fluid to initiate achemiluminescent reaction, if the test ATP reacts with the reagent inthe assay fluid; after a preselected time interval. The time interval,of course, varies as a function of several factors not relevant to thepresent invention. Timing such intervals is accomplished by means of asuitable timer 95 mounted on the device in any appropriate fashion andin exposing relationship (not shown) to the film unit. For example, thetimer can be started when the sampling rings are immersed into the assayfluid. Following the prescribed time period for generating luminescentreactions, as indicated by the timing device, the sample carrier isrotated to the film exposing position. During rotation, the opening pinengages the shutter and drives the latter to its unblocking condition,while the closing pin correspondingly disengages the shutter; wherebythe film aperture is opened so that the film can be exposed. It will beunderstood that displacement stops (not shown) for controllingdisplacement of the sample carrier can be appropriately provided.Accordingly, the film can be exposed by luminescent activity, assumingone, of course, occurs. The time interval for such an exposure can varyupon several factors including the speed of the film. Actuation of thetimer 100 can occur manually or even automatically as, for example, inresponse to movement of the sample carrier by carrier drive means (notshown). The present invention envisions the use of film printabledevices, such as LED's (not shown) that would be attached to the housingand otherwise actuatable to record desired information.

To process the latent luminescent images on the film, the film tab ispulled, whereby the film unit emerges from the housing through theprocessing rollers. As a result thereof, processing of the film units isinitiated. Because of the frangible connection between each of theunits, the unit pulled from the device separates and the next successivefilm unit is indexed to the exposure position for another test as aresult of the pulling action on the strip. For instance, the test willindicate either a positive or negative result in a manner that isquickly and easily ascertained. The result is simple to read andunderstand and is one that does not require user interpretation, such asdetermining the color of a test result or calculating anyquantification. It will be appreciated that as a consequence, a safe andsimple diagnostic test is performed that provides a positive record ofthe test being conducted. Such testing is of particular benefit,particularly in the home testing market wherein it can be used for avariety of diagnostic tests with a certainty of results and asignificant ease of operation.

As shown in FIG. 3, the sample carrier barrel need not have the openingand closing pins acting in cooperation with a shutter and, in fact, doesnot cooperate with a shutter. Rather, the sample carrier barrel, ineffect, acts as a shutter. Towards this particular end, a bottom surfaceof the barrel is covered by a light-blocking material 98 that has alow-coefficient of friction, such as felt. While felt is disclosed inthis embodiment, the present invention envisions a variety of materialsthat can be used in an equivalent manner. An opening in the felt iscoincident with the passage 56. The felt or other similar materialsprovide obviate the need for a shutter and shutter actuating mechanism.In addition, the present invention contemplates the use of a solenoidactuated shutter that would be operated by a suitable energizing meansand provide somewhat greater control over the shuttering functions.

Reference is made to FIGS. 4 and 5 for illustrating another preferredembodiment of a multiple-sample processor 100 made according to thepresent invention. Structure of this embodiment similar to that of theprevious embodiment will be indicated by like reference numerals withthe addition of a prime mark. The sample processor 100 includes ahousing assembly 102 and a sample carrier assembly 104 that arecooperable with each other in a manner to be described. Included in thehousing are generally rectangular and matable lower and upper processorportions 106 and 108 which form a light-tight enclosure for housing afilm assemblage 20′ like that described last-noted embodiment.Accordingly, a leading one of the film units is in a position forexposure within the housing and its tab 20 a protrudes. The housingportions are hingedly connected as at 112 to permit loading of a filmbox 114 that is loadable within a complementary shaped compartmentwithin the housing. The housing assembly 102 is, preferably, dimensionedto be hand-held and portable for convenient use in the field. Thehousing portions are made of any material suitable to define,preferably, a light-tight enclosure. While a hinged coupling isdescribed, a wide variety of approaches for joining the two opposedhousing components are envisioned. The lower processor housing portion106 is similar in construction to that described in the last-notedapplication. Basically, it includes a film supporting wall (not shown) aprocessing fluid spreading structure 30′ (not shown) for spreading theprocessing fluid ruptured from the pod in a well-known manner. A lowerspread roller 34′ is rotatably supported in the lower housing portionfor cooperating with a biased upper spread roller 36′ in the upperhousing portion 28 to define a pressure nip. The spread rollers serve torupture the pod and spread the processing fluid. In addition, the nipthereof acts to inexpensively retain the film assemblage within thehousing prior to use of the device. Accordingly, the film can betransported and handled without fear of it becoming dislodged orotherwise separated.

The upper housing 108 has a generally parallelepiped construction with agenerally rectangular recess 120 and houses generally a pivoting shutterplate 122 having a pair of light blocking arms 124 and 126 that areselectively movable with respect to openings 128 and 130 in the bottomof the well. The shutter plate 122 is resiliently biased by a spring 123to a solid line position with respect to the housing so as to be in alight-blocking relationship to the film whereby, the film openings 128,130 are not in registry with the openings 148 and 148′; respectively.The shutter plate is movable to a light-unblocking relationship when thecarrier is inserted within the processor so that the openings 128 and130 will be in registry with the openings 148 and 148′; as will bedescribed.

The sample carrier assembly 104 includes an elongate handle portion 132,an assay holder tray 134, for holding assay test strips 136, 136′, atray cover 137, and a tab guide 138. The holder tray 134 and cover areremovably held within a recess formed in the handle 132 and held bymeans of a frictional fit or other suitable means. In this embodiment,the upper surface of the tray includes, preferably, a pair of moldedgrooved arrangements 140, 140′. The molded grooved arrangement 140 isfor the test sample and the arrangement 140′ is for allowing theperformance of a control test being conducted with the test sample. Eachone of which defines a generally rectangular test strip receiving well142, 142′. Since both grooved arrangements are identical inconstruction, only the structure of one will be described. The receivingwell 142 is in fluid communication with a capillary type fluid deliverychannel 144 that is, in turn, in fluid communication with test fluidreservoir 146. The reservoir 146 is for receiving a biological testfluid introduced therein by any suitable means, such as a pipette; notforming a part of this invention. A light transmitting aperture 148 inthe well 142 is in optical registry with the opening 128 and thus withthe image recording area of the film when the shutter blade is in itsexposing position. Movement of the shutter blade to its opening positionoccurs in response to the tray engaging a resiliently bendable tab 125(FIG. 5) as the tray is inserted into a rectangular opening 150 formedin a side of the housing assembly and overcoming the bias of the spring.The test strip 136 is a suitably dimensioned chemiluminescent testingassembly or assay test strip for interacting with a preselected reagent,such as an analyte. The analyte is carried in a biological fluid testsample that is delivered to the reservoir and from the reservoir via thefluid delivery channel 144 to the test strip. The test strip can beconstructed from any of a wide variety of materials so long as itgenerates a luminescent signal capable of being recorded on film inresponse to interacting with a reagent carried in the test fluid. Thecapillary delivery channel 144 is comprised of a labyrinth groovedconstruction that is molded in the upper surface and serves to transferthe test fluid sample in a light-tight relationship from the reservoirto the well by virtue of capillary action. Therefore, it will beappreciated that the delivery channel 144 is constructed and dimensionedto induce or allow capillary action to transfer the test fluid from thereservoir to the well. In this embodiment, the walls defining thedelivery channel 144 have a depth in the order of about 0.005 inch to0.0024 inch in order to transfer the fluid by virtue of capillaryaction. The fluid reservoir 146 is of sufficient size to accommodate thequantity of test fluid to be deposited therein and, as noted, is influid communication with the channel 144. The cover 137 is generallyrectangular and has a fluid reservoir opening 156 in coveringrelationship to the grooved arrangements 140, while a fluid port 158 isin communication with the grooved arrangement 140′ for delivering thecontrol fluid. The control fluid will yield a chemiluminescent responsewith the assay strip 136′.

The cover 137 is suitably joined, as by heat bonding or ultrasonicwelding to the tray. The fluid opening 156 is in direct fluidcommunication with the reservoir 146 for allowing delivery of the testfluid, as by a pipette, to the reservoir. The cover 137 can, if desired,be removably joined to the upper housing portion should it be sodesired. In addition to the capillary action provided by the channels,the present invention contemplates that use of a wicking device made ofsuitable material (not shown) that can be added to the channels 144,144′ to assist in transferring the test fluid. It is equally clear thatthe present invention envisions substituting a wicking system for thecapillary channel itself. While one particular molded arrangement isillustrated for effecting the capillary flow, a wide variety ofconfigurations and dimensions can be used for transferring the fluid. Itis further envisioned that other than liquid actuated systems arecontemplated, such as gaseous mediums. The tab guide 138 includes twospaced apart semi-circular parts that are adapted to surround theprotruding tab 20 a so as to inhibit the user pulling on the film unituntil exposure is complete as determined by the type of chemiluminescentreaction occurring. Of course, suitable timing and/or printingmechanisms can be provided either in an integrated fashion with thedevice or separate therefrom. Removal of the test sample carrier allowsthe user to pull on the tab and commence processing of the latentimage(s) on the film. Also the shutter returns to the light blockingcondition and the tab 20 a returns to a position which allows it to beengaged by the tray.

After explaining the construction, the operation thereof isself-evident. However, the following brief description of the operationis provided as a supplement. An operator introduces a test fluid samplethrough the reservoir opening 156, as by a pipette, into the reservoir.The test fluid sample is transferred by reason of the capillary actioninduced by the capillary channel 144 to the test strip. If the testfluid contains the analyte being tested for, a chemiluminescent reactionoccurs after a prescribed period of time. This generated signaltransmitted to the film through the aligned openings 148, 128, 124 foreffecting exposure. As long as the carrier remains inserted, alight-tight condition exists for proper exposure.

In order to process the latent image, the protruding tab 20 is pulledafter the noted prescribed period of time, for example sixty (60)seconds. As noted, the pressure applying rollers rupture the pod andspread the fluid to develop any latent image generated by thechemiluminesence. Although a pair of a test strips is shown, additionaltests with additional assay strips can be provided.

FIGS. 6 and 7 schematically depict use of an optical filteringarrangements 180, 182; respectively, for quantifying the results of theluminescent signals that are provided. In this embodiment, the filteringarrangement 180 comprises a flat filtering disk adapted to be positionedunder the exposure aperture and is operable, in combination with thegenerated luminescent signals, for showing different light values on thefilm. In this embodiment, provision is made for three neutral densityfilters 186, 188 and 190 arranged as depicted that are separated andhave decreasing transmissivity (e.g., 1 or 2 stops) characteristics tothe light. Filter 186 is selected to allow the most light to the filmand the filters 188 and 190 are graduated to require increasingly higherlight levels to pass on the film. It will be appreciated that the higherthe light level generated the greater the chemiluminescent activity isproduced. Thus, the size of the chemiluminescent image will beproportional to the intensity of the reaction. In this manner, thechemiluminescent activity can be quantified by its size to indicate, forexample, the degree to which a surface is contaminated bymicroorganisms.

FIG. 7 depicts another embodiment of an optical filtering arrangement182 that is particularly adapted for use as an overlay to the film thatis being exposed. The filter includes a transmissive center 192, anopaque ring 194, a transparent ring 196 with indicia 198 thereon incombination with the devices of the present invention. The filterinclues when compared to the alternating transparent rings 184, 186 andfiltered rings 188, 190. Indicia 192, such as the term “positive” can beprinted on the transparent rings, so as to assist the user in properassessment of the test results. In this embodiment, the filter rings canbe made neutral density filters that have light attenuatingcharacteristics in the order of about one (1) or two (2) stops. Thelight attenuating characteristics can, of course, vary depending on theamount of light that is anticipated to be generated. Thus, if arelatively small spot is generated and appears visible only through thecenter only, such might be indicative of test results that areinconclusive; thereby requiring the performance of additional tests. Ifof course, no signal is generated, then the test is negative. If thereis a sufficient signal, it will generate a spot visible through thetransparent ring. While the foregoing embodiment discloses use ofneutral density filters, the present invention is not so limited andencompasses other optical filtering arrangements. Although not shown,the present invention contemplates having the film pre-exposed withimages, such as spots, having different sizes. The sizes would generallycorrelate to the size of spots that would be produced by luminescentsignals indicative of, for example, the intensity of the ATP reaction ina test sample. This would assist in the quantificaion of test outputs.Alternatively, an overlay (not shown) could be placed over the filmwith, for example, the same type of spot gradation in order to comparethe test signal exposure spot with these pre-exposed spots in order toassist in the quantification of the resultant luminescent signal.

FIG. 8 illustrates schematically another embodiment of the versatile,hand-held assay system 200. In this version, however, the luminescentread-out signal of the ampoule, for example, is read by any suitablesolid-state photodetector, such as a CCD 202. The exposure of the CCD isunder the control of a shutter mechanism 201, which may be of theelectromagnetic type. The CCD 202 is placed beneath the ampoule and inregistration to the exposure aperture and is operably connected to aprint driver in print head controller 204 that drives a light source ina light-tight enclosure; such as a plurality of LED's 206. Operation ofthe LED's 206 exposes a film units of a film assemblage 16. The LED'sfor instance, can be illuminated to provide qualitative and quantitativeinformation which is sensed from the CCD 202. For example, LED patternsindicative of the relative strength of the luminescent signal can beprinted on the film. The exposed film unit is processed as indicatedpreviously. Other light and image forming sources can be used, such asLCD's or vacuum florescent tubes for printing a variety of information.Also, other control devices, such as a microprocessor can be used in avariety of ways.

FIGS. 9 and 10 illustrate yet another preferred embodiment of thepresent invention. FIG. 9 illustrates a processor 300 which includes alight-tight housing 302 having an open top end 304 in which is rotatablea barrel 306 similar to that which is described in the first embodiment.This version is rotatable, preferably manually, about vertical axis 308.The barrel 306 includes a plurality of openings 310, one of which isillustrated. Each of the openings 310 is adapted to removably receive agenerally cylindrical test container assembly 312. The test container312 comprises in essence to lower and upper reservoirs 314 and 316;respectively. The reservoirs are made of a suitable material such asplastic. The reservoir 314 includes a transparent cylindrical closed endwall 318 that allows the luminescent signal to pass therethrough andexpose the film through the bottom opening of the barrel. The reservoir314 includes a mounting flange 320 that is adapted to seat againstcomplementary structure (not shown) within an opening 310. A penetrablesealing membrane 322 made of a suitable material such as described abovecovers the open end of the reservoir 314. A luminescent testing fluid324 is sealingly housed in the lower reservoir 314.

The upper reservoir 316 has a cylindrical configuration with an open endthat is threadedly fastened as at 326 to the exterior surface of theopen end of the lower reservoir 314. An actuator member 328 protrudesfrom one end of the upper reservoir 316 and is adapted to be slidablewithin an end plug 330. The upper reservoir 316 holds a fluid 332capable of mixing with an analyte of interest obtained through samplingin a manner to be described. The actuator member 328 is adapted to beurged into the reservoir, as when the cover 335 closes the upper end ofthe housing 302 so that its tip will penetrate the membrane 322. Thisaction thereby allows the fluid 322 that has been mixed with the analyteof interest to flow by gravity into the reservoir 314 wherein they reactwith the testing fluid 324. Consequently, should a chemiluminescentreaction occur it will be transmitted through the opening to the film orany other suitable image recording assembly, such as a CCD.

In use, an operator would separate the reservoirs by unfastening them.The operator would after taking a test sample, such as by swabbing apatient's throat insert the swab into the fluid contained in the upperreservoir and then reconnect the two reservoirs. A test container wouldbe inserted into one of the openings 310 in the barrel 302, so that thetransparent wall 318 is seated in close proximity to the bottom of thebarrel. The barrel is rotated so that the bottom of each of therespective openings 310 is in registry with a corresponding aperture(not shown) in the bottom wall of the housing. The apertures are inoptical communication with the film; which is preferably of theself-developing type. As noted there is a light-tight relationshipbetween the barrel and the housing apertures. When the cover 335 isclosed it drives the actuator 328 downwardly sufficiently to penetratethe membrane 322. This allows the fluid in the upper reservoir to mixwith the fluid 324 in the lower reservoir for commencing achemiluminescent reaction. Closing of the cover 335 can also serve toprevent removal of the film through any suitable interlock (not shown)with a film advancing system not shown but well-known in the field ofprocessing self-developing film units. It will be appreciated that motorcontrols can be provided to this system for rotating the barrel. Thebarrel when rotated can actuate a switch to in turn actuate a lockingdevice (not shown) that locks the cover and or barrel in place therebypreventing premature removal of the test container or movement of thebarrel. As noted a suitable interlock can prevent premature withdrawalof the film until a predetermined time has elapsed.

Although the foregoing invention has been described in some detail, itwill be readily apparent to those of ordinary skill in the art thatcertain changes and modifications may be made thereto without departingfrom the spirit and scope of the appended claims.

What is claimed is:
 1. A portable diagnostic assay system for conductinga luminescent test and recording luminescent signals generated therebyon an image recording material, the system comprising: a processorincluding a portable, hand-held and light-tight housing having first andsecond openings, and a shutter mechanism within the housing and beinglocated at an exposure station so as to be operable for operationbetween unblocking and blocking conditions relative to at least oneexposing aperture in response to corresponding insertion and removal ofa removable sample carrier from the housing; and, a fluid processingassembly in the housing for processing self-developing film units; atleast one luminescent testing assembly capable of generating aluminescent activity; a sample carrier that carries the testing assemblyand is insertable in and withdrawable from the second opening foroperating; said sample carrier being constructed to activate the shuttermechanism to the unblocking condition when inserted into the secondopening, and allow the shutter mechanism to return to the blockingcondition when removed from the second opening; whereby when the shuttermechanism is in the unblocking condition a luminescent reactionconducted on the film assemblage can expose the film through theexposure aperture; and, an image recording assemblage is housed in theprocessor at the exposure station.
 2. The system of claim 1 whereinimage recording assemblage is a self-developing integral film unithaving an image recording area and a pod of processing fluid, the filmunit is housed in the processor at the exposure station; and is capableof being processed as it advances from the housing.
 3. The system ofclaim 2 wherein the film assemblage has a leading portion thereofextending from the first opening in the housing; and the assemblage ispullable from the first opening so that the exposed image area thereofcan be have its latent image processed by the fluid processing means asthe assemblage is pulled from the housing.
 4. A hand-held, portablediagnostic assay system for conducting and recording luminescentreactions that generate luminescent read-out signals which arerecordable on an image recording medium, the system includes a housingassembly defining a light-tight enclosure carrying at least the imagerecording medium, and an exposure opening that optically communicatesthe recording medium with the luminescent signal; a carrier assembly hasone condition for receiving a luminescent testing assembly that iscapable of generating the luminescent read-out signal recordable on therecording medium through the exposure opening, and a second condition inwhich the carrier assembly is inserted through an opening in the housinginto the enclosure for allowing the recording medium to be exposed withthe luminescent signal, wherein said test assembly includes a containerhaving a transparent bottom portion that is insertable into an openingin the carrier assembly, the carrier assembly opening being out ofoptical communication with the exposure opening when the carrierassembly is in the first condition and in optical communication when thecarrier assembly is in the second condition, whereby a luminescentsignal is recordable on the recording medium when the carrier assemblyis in its second condition, and wherein said test container comprises areservoir that stores a luminescent testing fluid that is sealed by asealing membrane; and, a sample testing device which contains a sampleto be tested and is inserted into the container such that it penetratesthe sealing membrane such that the sample testing device cooperates withthe sample fluid.
 5. The system of claim 4 further including ashuttering mechanism in operative relationship to the enclosure andwhich moves into an exposing condition relative to the exposure openingwhen the carrier is inserted into the enclosure and returns to a lightblocking condition relative to the exposure opening when the carrier isremoved from the enclosure.
 6. The system of claim 5 wherein the imagerecording medium is a self-developing film unit which is processed asthe film unit is advanced from the housing after passing therethrough.7. The system of claim 4 wherein the luminescent testing assemblyincludes a sampling device which can sample a surface to be tested andthen be inserted, in a light-tight manner, within the test containersuch that a portion thereof penetrates the membrane and is immersed inthe fluid.
 8. The system of claim 4 wherein the carrier assembly isrotatable in the housing from the first condition wherein thetransparent reservoir portion is out of registry with the exposureopening and the exposure opening is blocked from light to the secondcondition wherein the transparent reservoir portion is in opticalcommunication to the exposure opening for exposing the film.
 9. Thesystem of claim 8 wherein the carrier assembly includes a cover membermovable from a position for allowing the fluid container to be insertedinto the carrier assembly opening to a light-tight position over thefluid container, wherein the cover member causes an actuating member ofthe fluid container to penetrate the sealing membrane so that fluid ofone reservoir in the fluid container can mix with the luminescenttesting fluid for generating the read-out signal.
 10. The system ofclaim 8 wherein the fluid container includes first and second separablereservoirs, the first contains the luminescent testing fluid and issealed by the sealing membrane, the first reservoir includes transparentwalls for allowing a luminescent read-out signal to expose the imagerecording medium; the second reservoir includes an actuating element atone end thereof, the second reservoir being separable from the firstreservoir and contains a fluid into which a reagent of interest can beinserted, such that the actuating element when actuated penetrates themembrane to allow the fluid and analyte of interest to mix with thetesting fluid for commencing a luminescent reaction.
 11. The system ofclaim 4 further including means for effecting and recording aluminescent read-out signal of a control test in addition to theluminescent read-out signal of a test sample.
 12. The system of claim 4wherein the carrier assembly carries the luminescent sample testassembly and a luminescent control test assembly, the carrier assemblyalso includes fluid transfer means for allowing transfer of the controland test fluids; respectively, from separate ports in the housing to therespective test assemblies.
 13. The system of claim 12 wherein the fluidtransfer means comprises capillary grooves in a light-tight arrangement.14. The system of claim 4, further including means for quantifying theluminescent read-out signal generated and recorded on the film.
 15. Thesystem of claim 14 wherein the quantifying means includes an opticalfilter element comprising a series of alternating transparent and opaquezones that act to delineate different sized read-out signals; wherebydifferent sized developed latent images correlate to correspondingdifferent test results, thereby providing a visual measurement of thetest results.
 16. The system of claim 15 wherein the quantifying meansincludes a series of existing symbols of different sizes on the filmwherein each size corresponds to a different strength of a read-outsignal, so that the read-out signal captured by the test can be comparedto the different symbols.